Vaginismus, is the physical or psychological medical condition which affects a person's ability to engage in any form of vaginal penetration. Such can include sexual intercourse, insertion of tampons or menstrual cups, as well as the penetration involved in gynecological examinations (pap tests).
The condition is presumed to be the result of an involuntary vaginal muscle spasm, which makes any kind of vaginal penetration, including sexual intercourse painful or impossible. While there is currently a lack of medical evidence to definitively pinpoint a cause and which muscle is responsible for the spasm, the pubococcygeus muscle, sometimes referred to as the “PC muscle”, is most often suggested by medical professionals. Other muscles such as the levator ani, bulbocavernosus, circumvaginal, and perivaginal muscles have also been suggested as a cause or contributing factor to the problem.
A person suffering from vaginismus does not consciously control the spasm. The vaginismic reflex can be compared to the response of the eye shutting when an object comes towards it. The severity of vaginismus, as well as the pain during penetration (including sexual penetration), varies from person to person.
Conventionally, there are products on the market employed to treat this condition. The currently available products employ a graduated set of vaginal inserts for employment in the treatment of vaginismus, various pelvic floor disorders, or to rehabilitate a patient following surgery.
The conventional product can generally be divided into inserts which are flexible or inserts which are rigid. Amongst these two types of products, some employ handles and some do not.
Conventional products which do provide flexible vaginal inserts of various sizes have significant limitations. Such products do not provide handles and are, thus, difficult to grip by the user and subsequently employ. Without handles, it is difficult for a user to communicate pressure to the insert and thereby against muscle and tissue which helps with the rehabilitation process. Additionally, because the insert is generally lubricated for user comfort, the lack of a handle invariably causes the employed lubricant to transfer to the user's hands making a mess, and making it more difficult to grip the dilator insert during use effectively.
Additionally, the flexibility of such conventional inserts, is generally achieved by the employment of thick rubber or silicone to form a solid body or thick wall body of the insert. This construction renders the inserts heavy and stiff. Since with the conventional design, the silicone or rubber material of the body of the insert, must be thick enough to withstand collapse of the sidewalls defining the exterior surface.
This required thick or solid form construction renders these inserts more expensive to manufacture and ship as well as being less flexible than might be desirable by the user. Further, so constructed, the inserts are too thick to nest for shipping thereby making shipping packages larger and more expensive.
Finally, the flexibility of such inserts is generally very limited even though they are sold for this ability. This is because, as noted, the traditional design requiring thick walls, along with a durometer stiffness of the material to maintain structural integrity, severely limits the desirable cushioning for the insert and flexibility.
With regard to insert products which are formed of hard materials or inflexible materials, in addition to lacking desirable flexibility and cushioning, other aspects are lacking. Many such devices in this configuration either don't have a handle, or if they do have a handle, the handles provide a very weak frictional engagement which causes the insert to dismount too easily. As can be discerned, such causes a patient user significant distress and frustration during use.
Further, a number of available products using a handle engageable to the insert, employ a handle having projecting annular ridge portions, to accommodate different sized insert mounting. However, such devices leave projecting ridge portions, unused by other inserts, exposed which act like uncomfortable projections which scrape or bind upon the patient's skin and soft tissues during use.
Finally, many of the products of both types noted above have poor ergonomic configurations and shape at the distal end employed for insertion. They lack an egg or curved shape allowing for more comfortable communication during insertion and additionally lack a tapering of the insert from a narrower distal end to a wider base to allow for a more gradual insertion process.
As such, there exists an unmet need for a dilation device and method which remedies the noted shortcomings in the current art. Such a system should provide an easily gripped handle having a dilator mount at one end. The dilator mount should provide an engagement system which will engage any of a large plurality of different insert components with the same mount. Once an insert is engaged, no ridges or gaps would be present at the engagement point of the insert to the handle and only a smooth surface should be presented which eliminates the discomfort noted in current systems. Finally such a system should provide dilators engageable to the common handle which vary in size, and vary in overall stiffness to allow for inserts which will bend during use. This bending should be provided by a flexible skeletal system covered by soft polymeric material to provide maximum flexibility with maximum comfort to the user.
The forgoing examples of related art and limitations related therewith are intended to be illustrative only, and not exclusive, and they do not imply any limitations on the invention described and claimed herein. Various other limitations of the related art will become apparent to those skilled in the art upon a reading and understanding of the specification below and the accompanying drawings.